External preparation composition

Abstract

To provide a composition for external application that allows a medicinal component to be sustained-released to the skin in a continuous manner, can readily form a coating on the skin, with high skin coatability and quick dryability, and allows reduction in the stickiness and tightness of the formed coating, the coating having improved appearance and durability.SOLUTION: A composition for external application comprises (A) a medicinal component, (B) a water-insoluble polymer, (C) a nonvolatile base, (D) a volatile solvent, and (E) water, wherein the viscosity at 25°C is 1.0 mPa s or more and 10,000 mPa s or less.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an external preparation composition. [Background technology]

[0002] Liquid topical skin preparations and patches containing medicinal ingredients such as anti-inflammatory and analgesic ingredients, bactericidal and disinfectant ingredients are known. However, existing liquid topical skin preparations have problems such as being easily rubbed off by clothing after application to the skin, making it difficult to continuously release the medicinal ingredients to the skin. Patches containing medicinal ingredients also have difficulty in continuously releasing the medicinal ingredients to the skin if they do not easily conform to the skin and are easily peeled off. On the other hand, patches that are highly adhesive to the skin also have the problem of placing a heavy burden on the skin when peeled off. Patches also have practical use issues such as being prone to rashes and having an unsightly appearance when applied to the skin.

[0003] Therefore, film-forming preparations that can continuously release medicinal ingredients onto the skin have been studied. Film-forming preparations can form a film when applied to the skin, so they are less likely to rub off than liquid topical skin preparations. They are also preferred in that they are not noticeable when applied to the skin like patches and cause less stress on the skin when removed.

[0004] For example, Patent Document 1 proposes an adhesive solid formulation for skin delivery of drugs, which comprises a drug; a solvent excipient, which comprises a volatile solvent system that comprises a volatile solvent and a non-volatile solvent system that comprises a non-volatile solvent; and a solidifying agent; and has viscosity suitable for application and adhesion to skin surface before the evaporation of the volatile solvent system, and the formulation applied to the skin surface forms a solidified layer after at least partial evaporation of the volatile solvent system, and the drug continues to be delivered to the skin after the volatile solvent system has at least substantially evaporated, and there are at least two volatile solvents, two non-volatile solvents, or two solidifying agents.It is stated that this formulation can provide sustained drug delivery for a long time, is not vulnerable to unintentional removal by contact with clothing, other objects, or people during the duration of application, can be applied to the skin area that follows stretching and expansion without causing unpleasant or poor contact with the skin, and can be easily removed after application and use.

[0005] Patent Document 2 proposes a composition for transdermal administration of a physiologically active agent, which comprises an ethyl acrylate / methyl methacrylate copolymer, ethanol, isopropanol or a mixture thereof, water, and at least one physiologically active agent. The composition is described as a film-forming composition that rapidly forms a non-sticky, durable, and very soft film. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Special Publication No. 2009-519956 [Patent Document 2] Special Publication No. 2014-515365 Summary of the Invention [Problem to be solved by the invention]

[0007] However, even in the techniques disclosed in Patent Documents 1 and 2, there is still room for improvement in the sustained release of drugs, physiologically active agents, etc. into the skin. In addition, improvements in the practical performance of topical compositions, such as quick drying after application to the skin and appearance, are also desired. The present invention relates to an external preparation composition that can sustainably release a medicinal ingredient onto the skin, has good film-forming properties, is easy to apply to the skin, dries quickly, and has an effect of suppressing stickiness and a feeling of tightness in the formed film, and is also excellent in appearance and durability of the film. [Means for solving the problem]

[0008] The present inventors have found that an external preparation composition containing a medicinal ingredient, a water-insoluble polymer, and a predetermined solvent component and having a predetermined viscosity can solve the above problems. That is, the present invention relates to the following. [1] A topical composition containing (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity at 25°C of 1.0 mPa·s or more and 10,000 mPa·s or less. [2] A lotion, gel, ointment, cream, or foam formulation comprising the topical composition according to [1] above. [3] An aerosol formulation or pump spray formulation using the topical composition described in [1] above. [4] A method for using an external preparation composition, comprising the steps of applying to the skin an external preparation composition containing (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity at 25°C of 1.0 mPa·s or more and 10,000 mPa·s or less, and then drying the composition. [5] A method for producing a coating, comprising the step of applying the topical composition described in [1] above to the skin by directly applying or spraying it. [Effects of the Invention]

[0009] According to the present invention, it is possible to provide an external preparation composition that can sustainably release a medicinal ingredient onto the skin, has good film-forming properties, is easily applied to the skin, dries quickly, and has the effect of suppressing stickiness and a feeling of tightness in the formed film, and is excellent in appearance and durability of the film; a preparation using the same; a method for using the external preparation composition; and a method for producing the film. DETAILED DESCRIPTION OF THE INVENTION

[0010] [External preparation composition] The present invention relates to a topical composition containing (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity of 1.0 mPa s or more and 10,000 mPa s or less at 25° C. Hereinafter, this composition will also be referred to as the "composition of the present invention" as appropriate.

[0011] <Definition> As used herein, the term "external preparation composition" refers to a composition that is primarily applied to the skin surface. As used herein, the term "water-insoluble polymer" refers to a polymer that has the property that, when 1 g of the polymer is immersed in 10 g of ion-exchanged water under an environment of 23°C and 1 atmosphere, more than 0.5 g of the immersed polymer does not dissolve after 24 hours. As used herein, the term "non-volatile base" refers to a base that is liquid at 70°C and exhibits a mass loss of less than 1% after 1 g of the base is spread on a 48 mm diameter glass petri dish and left at 25°C and atmospheric pressure for 24 hours. "Volatile solvent" means that 1 g of the solvent is spread on a glass petri dish with a diameter of 48 mm, and after being left at 25°C and normal pressure for 24 hours, the mass loss rate is 1% or more, the solvent is liquid at 25°C, and the solvent contains components other than water. In this specification, the resistance of the coating to sweat, humidity, etc. (moisture resistance) and the resistance of the coating to being rubbed off (abrasion resistance) are collectively referred to as "durability of the coating."

[0012] The composition of the present invention contains component (A): a medicinal ingredient, component (B): a water-insoluble polymer, component (C): a non-volatile base, component (D): a volatile base, and component (E): water, but component (A) is a component that is not contained in any of the other components (B), (C), and (D), and component (B) is a component that is not contained in any of components (C) and (D).

[0013] The composition of the present invention, having the above-mentioned constitution, can sustainably release the medicinal ingredient to the skin, has good film-forming properties, is easy to apply to the skin, dries quickly, and has an effect of suppressing stickiness and a feeling of tightness of the formed film, and has excellent appearance and durability of the film. The reasons for this are not clear, but are thought to be as follows. The composition of the present invention is a film-forming composition that contains, as film-forming components, a water-insoluble polymer as component (B) and a non-volatile base as component (C). When the composition of the present invention is applied to the skin and then dried, components (D) and (E) volatilize, forming a film containing components (A) to (C). Here, when a highly crystalline component such as felbinac, which will be described later, is used as the medicinal component (A), if the compatibility between component (A) and the coating is low, component (A) is likely to crystallize in the coating, resulting in a decrease in sustained release to the skin. However, if the compatibility between component (A) and the coating is too high, component (A) is likely to be taken up into the coating, making it difficult to sustainably release it to the skin. When a water-insoluble polymer, component (B), is used as a film-forming component, the compatibility between the coating and component (A) may become excessively high or low, possibly resulting in a decrease in the sustained release of component (A). In the composition of the present invention, the use of component (C) is thought to reduce the compatibility between the coating and component (A) when the compatibility between the coating and component (A) is excessively high, or to improve the compatibility when the compatibility between the coating and component (A) is low, thereby suppressing the crystallization of component (A), thereby improving the sustained release of component (A). Furthermore, because component (B) is water-insoluble, it can form a highly hydrophobic coating, which makes it difficult for the coating to rub off due to sweat, humidity, etc. after application to the skin, enabling the sustained release of the medicinal ingredient into the skin. Furthermore, the synergistic effect of components (B) and (C) is believed to result in a composition that is easy to apply to the skin, dries quickly, is free from stickiness and tightness, has a good appearance, and is capable of forming a coating that is difficult to rub off after application to the skin and has good durability. It is believed that component (D) contributes to improving the composition's application properties, quick-drying properties, storage stability, etc., and component (E) contributes to improving the composition's storage stability. Furthermore, since the composition of the present invention contains components (D) and (E) and has a viscosity within the specified range, the composition becomes more compatible with the skin, achieving both film-forming properties and film durability, as well as application properties and quick-drying properties, and as a result, it is believed that component (A) can be effectively and sustainedly released onto the skin.

[0014] <Ingredient (A): Medicinal ingredient> The composition of the present invention contains a medicinal ingredient as component (A). From the viewpoint of use in a topical preparation composition, component (A) is preferably a skin topical ingredient that can be administered transdermally. Specifically, component (A) preferably contains one or more selected from the group consisting of anti-inflammatory and analgesic ingredients, local stimulating ingredients, blood circulation promoting ingredients, antihistamine ingredients, herbal ingredients, antipruritic ingredients, local anesthetic ingredients, keratin softening ingredients, bactericidal ingredients, and antibacterial ingredients.

[0015] Anti-inflammatory and analgesic ingredients include glycol salicylate, methyl salicylate, aspirin, sulpyrine hydrate, acetaminophen, diclofenac sodium, fenbufen, ibuprofen, aminoprofen, loxoprofen sodium or its hydrate, naproxen, oxaprofen, ketoprofen, tiaprofenic acid, sulindac, aluminum flufenamate, felbinac, mefenamic acid, indomethacin, indomethacin farnesyl, acemetacin, and proglucan. Examples of such an active ingredient include tacin maleate, bendazac, piroxicam, ampiroxicam, lornoxicam, tenoxicam, meloxicam, etodolac, tiaramide hydrochloride, bucolome, flurbiprofen, es-flurbiprofen, lysozyme hydrochloride, bromelain, diphenhydramine hydrochloride, dibucaine, dimethylisopropylazulene, benzethonium chloride, glycyrrhizinic acid, dipotassium glycyrrhizinate, zinc oxide, allantoin, heparinoids, and glycyrrhetinic acid.

[0016] Examples of local irritating ingredients include l-menthol, dl-camphor, nonylic acid vanillylamide, ammonia, and peppermint oil.

[0017] Examples of blood circulation promoting ingredients include benzyl nicotinate, sodium polyethylene sulfonate, and tocopherol acetate.

[0018] Antihistamine ingredients include diphenhydramine, diphenhydramine hydrochloride, diphenhydramine salicylate, chlorpheniramine maleate, and the like.

[0019] Examples of herbal ingredients include chili pepper, eucalyptus oil, Phellodendron bark, arnica tincture, herb, peony, mugwort, cinnamon bark, Cnidium rhizome, Magnolia officinalis, Atractylodes rhizome, Illicium verum, cinnamon bark, tangerine peel, carrot, tangerine, clove, ginger, Chinese quince, licorice, fennel, Mokutzu, Kouka, Magnolia officinalis, spruce, and chinquapin.

[0020] Antipruritic ingredients include crotamiton, cortisone acetate, isothipendyl hydrochloride, benzalkonium chloride, calamine, d-borneol, aqueous ammonia, hydrocortisone, dorocortisone acetate, hydrocortisone butyrate, dexamethasone, dexamethasone acetate, prednisolone, prednisolone acetate, prednisolone valerate acetate, and ufenamate.

[0021] Examples of local anesthetic ingredients include lidocaine, mepivacaine, bupivacaine, ropivacaine, levopivacaine, dibucaine, dibucaine hydrochloride, and ethyl aminobenzoate.

[0022] Examples of keratin softening ingredients include urea, sulfur, and salicylic acid.

[0023] Antibacterial ingredients include chlorhexidine gluconate, copper chlorophyllin sodium, isopropylmethylphenol, cetylpyridinium chloride hydrate, benzethonium chloride, benzalkonium chloride, resorcinol, acrinol hydrate, chlorhexidine gluconate, povidone-iodine, iodine / potassium iodide, mercurochrome, hydrogen peroxide, cresol, iodoform, and thymol.

[0024] Antibacterial ingredients include undecylenic acid, zinc undecylenate, phenyl-11-iodo-10-undecynoate, exalamide, clotrimazole, econazole nitrate, miconazole nitrate, tioconazole, zinc diethyldithiocarbamate, ciclopirox olamine, siccanin, trichomycin, pyrrolnitrin, thianthol, 2,4,6-tribromophenylcaproic acid ester, trimethylcetylammonium pentachlorophenate, tolciclate, tolnaftate, haloprogin, Hibiscus bark, berberine benzoate, dequalinium chloride, chlorhexidine hydrochloride, chlorhexidine gluconate solution, dequalinium acetate, hinokitiol, revulcin, benzoic acid, chlorobutanol, acetic acid, phenol, tincture of iodine, diphenylpyraline hydrochloride, diphensalic acid Examples of antiperspirants include hydramine, diphenylimidazole, chlorpheniramine maleate, dibucaine hydrochloride, procaine hydrochloride, lidocaine hydrochloride, aldioxa, glycyrrhizic acid and its salts, Lithospermum Root, Angelica Root, Borneolum, diethyl phthalate, chlorohydroxyaluminum, penicillins, cephems, carbapenems, monobactams, penems, aminoglycosides, fosfomycins, chloramphenicols, macrolides, glycopeptides, quinolones, new quinolones, sulfa drugs, fradiomycin sulfate, gentamicin sulfate, pentamidine isethionate, silver sulfadiazine, oxiconazole nitrate, sulconazole nitrate, bifonazole, neticonazole hydrochloride, lanoconazole, tenafine hydrochloride, amorolfine hydrochloride, and terbinafine hydrochloride.

[0025] The component (A) can be one or more of the above-mentioned medicinal components. Among the above, from the viewpoint of being an external preparation composition to be used on exposed and flexed parts of the skin, component (A) preferably contains one or more selected from the group consisting of anti-inflammatory and analgesic components, local stimulating components, blood circulation promoting components, antihistamine components, and herbal ingredients, and more preferably contains one or more selected from the group consisting of anti-inflammatory and analgesic components and local stimulating components. Specifically, component (A) more preferably contains one or more selected from the group consisting of glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium, ketoprofen, felbinac, indomethacin, piroxicam, flurbiprofen, glycyrrhizic acid, glycyrrhetinic acid, l-menthol, dl-camphor, vanillylamide nonylate, peppermint oil, benzyl nicotinate, sodium polyethylenesulfonate, tocopherol acetate, diphenhydramine, chlorpheniramine maleate, capsicum, eucalyptus oil, and Phellodendron Bark.

[0026] The solubility parameter (SP value) of component (A) is preferably 15.00 or more, more preferably 18.00 or more, even more preferably 19.00 or more, and even more preferably 19.50 or more, from the viewpoint of ensuring that the coating film formed has a good appearance and suppressing the taut feeling of the coating film formed. Also, from the same viewpoint, it is preferably 35.00 or less, more preferably 27.00 or less, even more preferably 24.00 or less, and even more preferably 22.00 or less. The SP value of component (A) is preferably 15.00 or more and 35.00 or less, more preferably 18.00 or more and 27.00 or less, even more preferably 19.00 or more and 24.00 or less, and even more preferably 19.50 or more and 22.00 or less.

[0027] The SP value can be calculated using solubility parameter calculation software (Hansen Solubility Parameters in Practice 4th Edition 4.1.03). In this specification, the SP value is calculated based on the Hansen solubility parameter. The Hansen solubility parameter is a three-dimensional representation of the Hildebrand solubility parameter, which is divided into three components: a dispersion term δD, a polar term δP, and a hydrogen bonding term δH. Specifically, the SP value δ is calculated using the following formula: δ=(δD 2 +δP 2 +δH 2 ) 1 / 2

[0028] The SP value of a mixture of two or more components can be calculated as follows. For example, if a mixture of two components, component 1 and component 2, is called "mixture X," and the Hansen solubility parameters of components 1 and 2 that make up mixture X are [δD1, δP1, δH1] and [δD2, δP2, δH2], respectively, and the volume ratio of components 1 and 2 is V1:V2, then the dispersion term δDm, polar term δPm, and hydrogen bonding term δHm of mixture X can be expressed by the following equations. Note that in the case of polymers, the specific gravity was calculated as 1.0. δDm=(V1×δD1+V2×δD2) / (V1+V2) δPm=(V1×δP1+V2×δP2) / (V1+V2) δHm=(V1×δH1+V2×δH2) / (V1+V2) The SP value Δx of the mixture X is calculated using the following formula: δx=(δDm 2 +δPm 2 +δHm 2 ) 1 / 2

[0029] The composition of the present invention, even when a highly crystalline component (A) is used, can suppress crystallization of the component (A) in the coating, enhance sustained release onto the skin, and improve the storage stability of the composition. From the viewpoint of the usefulness of this effect, it is preferable that the component (A) is one or more crystalline active ingredients selected from the group consisting of glycol salicylate, loxoprofen sodium, felbinac, l-menthol, and vanillylamide nonylate. However, the composition of the present invention can also form a coating with high sustained release onto the skin when an amorphous component (A) is used.

[0030] <Component (B): Water-insoluble polymer> The composition of the present invention contains a water-insoluble polymer as component (B). Component (B) is a film-forming component that is thought to improve the film-forming properties and quick-drying properties of the composition, reduce stickiness of the film, and, through the aforementioned mechanism of action, enable the sustained release of component (A) onto the skin and the formation of a film with excellent appearance and durability. From the viewpoint of improving film-forming properties, component (B) is preferably a film-forming water-insoluble polymer, the definition of "water-insoluble" for component (B) being as described above.

[0031] The solubility parameter (SP value) of component (B) is preferably 17.00 or more, more preferably 18.00 or more, even more preferably 19.00 or more, and even more preferably 20.00 or more, from the viewpoint of suppressing the taut feeling of the formed coating and improving the sustained release of component (A) to the skin. Furthermore, from the viewpoint of suppressing the stickiness of the formed coating, improving the sustained release of component (A) to the skin, and improving the durability of the coating, it is preferably 27.00 or less, more preferably 25.00 or less, even more preferably 24.00 or less, and even more preferably 23.00 or less. The SP value of component (B) is preferably 17.00 or more and 27.00 or less, more preferably 18.00 or more and 25.00 or less, even more preferably 19.00 or more and 24.00 or less, and even more preferably 20.00 or more and 23.00 or less. The SP value can be calculated by the same method as above.

[0032] The type of component (B) is not particularly limited as long as it is a water-insoluble polymer, but from the viewpoints of suppressing stickiness and tightness of the coating, and improving compatibility with the skin, coating formability, and durability, component (B) is preferably one or more water-insoluble polymers selected from the group consisting of acrylic polymers, cellulose polymers, and vinyl polymers. More preferably, it is one or more water-insoluble polymers selected from the group consisting of acrylic polymers, cellulose polymers, and vinyl polymers, and having an SP value in the above-mentioned range.

[0033] The acrylic polymer used as component (B) may be a water-insoluble polymer containing at least a structural unit derived from a monomer having a (meth)acrylic group. In this specification, "(meth)acrylic" refers to both acrylic and methacrylic. Specific examples of the acrylic polymer include water-insoluble ones of (acrylates / diacetoneacrylamide) copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, acrylic acid-octyl acrylate copolymer, acrylic ester-vinyl acetate copolymer, 2-ethylhexyl acrylate-methyl acrylate-acrylic acid-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-vinyl acetate-hydroxyethyl acrylate-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-diacetoneacrylamide-acetoacetoxyethyl methacrylate-methyl methacrylate copolymer, 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, ethyl acrylate-methyl methacrylate copolymer, ethyl acrylate-methyl methacrylate copolymer, methyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate chloride copolymer, and methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer. Among the above, the (acrylates / diacetone acrylamide) copolymer is the cosmetic ingredient label name "(alkyl acrylate / diacetone acrylamide) copolymer AMP," the acrylamide-methoxy polyethylene glycol methacrylate copolymer is the "acrylic acid amide-methoxy polyethylene glycol methacrylate copolymer liquid" listed in the Pharmaceutical Excipients Standard 2018 (Pharmaceutical Examination and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare), and the 2-ethylhexyl acrylate-vinylpyrrolidone copolymer is the "2-ethylhexyl acrylate-vinylpyrrolidone copolymer." For the 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, "2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer solution" can be used; for the ethyl acrylate-methyl methacrylate copolymer, "ethyl acrylate-methyl methacrylate copolymer dispersion" can be used; and for the methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, "aminoalkyl methacrylate copolymer E" can be used. Furthermore, as the ethyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate chloride copolymer, "aminoalkyl methacrylate copolymer RS," which is known as a pharmaceutical additive, can be used.

[0034] The cellulose-based polymer used as component (B) includes water-insoluble polymers having a cellulose skeleton. Examples of the cellulose-based polymer include water-insoluble ones of methyl cellulose, ethyl cellulose, hypromellose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, and hydrophobized (C16-18) hydroxypropyl methyl cellulose.

[0035] The vinyl polymer used as component (B) is a water-insoluble polymer that contains at least a structural unit derived from a monomer having a vinyl group and does not belong to the acrylic polymers described above, such as polyvinyl alcohol and polyvinyl butyral.

[0036] One or more types of component (B) can be used. Among the above, component (B) is preferably an (acrylates / diacetoneacrylamide) copolymer, an acrylamide-methoxypolyethylene glycol methacrylate copolymer, an acrylic acid-octyl acrylate copolymer, an acrylic acid ester-vinyl acetate copolymer, a 2-ethylhexyl acrylate-methyl acrylate-acrylic acid-glycidyl methacrylate copolymer, a 2-ethylhexyl acrylate-vinyl acetate-hydroxyethyl acrylate-glycidyl methacrylate copolymer, a 2-ethylhexyl acrylate-diacetoneacrylamide-acetoacetoxyethyl methacrylate-methyl methacrylate copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, an ethyl acrylate-methyl methacrylate copolymer, an acrylic acid ester-vinyl acetate ...vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, an ethyl acrylate-methyl methacrylate copolymer, an acrylic acid ester-vinyl acetate copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethyl The polymerizable monomer is at least one selected from the group consisting of ethyl methacrylate-methyl methacrylate-trimethylammonium ethyl methacrylate copolymer, methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, methyl cellulose, ethyl cellulose, hypromellose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, hydrophobized (C16-18) hydroxypropyl methylcellulose, polyvinyl alcohol, and polyvinyl butyral, and more preferably at least one selected from the group consisting of acrylates / diacetone acrylamide copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, ethyl cellulose, hypromellose phthalate, and polyvinyl butyral, and having an SP value within the above range.

[0037] <Component (C): Non-volatile base> The composition of the present invention contains a non-volatile base (excluding those corresponding to component (A)) as component (C). Component (C) has a synergistic effect with component (B), which is thought to improve the film-forming properties, ease of application to the skin, and quick-drying properties of the composition, and also contribute to the sustained release of component (A) onto the skin and the storage stability of the composition. The "non-volatile base" of component (C) is as defined above.

[0038] Examples of component (C) include lipophilic bases, hydrophilic bases, and amphiphilic bases. From the viewpoint of improving the film-forming properties, application properties to the skin, and quick-drying properties of the composition, and from the viewpoint of enhancing the sustained release of component (A) to the skin, one or more selected from the group consisting of lipophilic bases and hydrophilic bases are preferred.

[0039] Furthermore, from the viewpoint of film-forming ability and improving the storage stability of the composition, component (C) is preferably a compound that does not contain an unsaturated hydrocarbon chain having 16 or more carbon atoms. From the viewpoint of film-forming ability and improving the storage stability of the composition, the content of the non-volatile base containing an unsaturated hydrocarbon chain having 16 or more carbon atoms in component (C) is preferably 30% by mass or less, more preferably 10% by mass or less, even more preferably 5% by mass or less, still more preferably 1% by mass or less, and even more preferably 0% by mass.

[0040] The lipophilic base preferably includes ester oil, non-polar oil, and the like. Specific examples of ester oils include non-volatile synthetic ester oils, and more preferably at least one selected from the group consisting of (i) fatty acid monoesters composed of fatty acids and monohydric alcohols, (ii) fatty acid diesters composed of fatty acids and dihydric alcohols, (iii) dicarboxylic acid diesters composed of dicarboxylic acids and monohydric alcohols, (iv) tricarboxylic acid triesters composed of tricarboxylic acids and monohydric alcohols, and (v) glycerin fatty acid triesters.

[0041] (i) Examples of fatty acid monoesters composed of fatty acids and monohydric alcohols include monoesters of saturated fatty acids having from 8 to 22 carbon atoms and aliphatic or aromatic ring-containing monohydric alcohols having from 1 to 24 carbon atoms, such as cetyl octanoate, cetyl 2-ethylhexanoate, ethyl laurate, hexyl laurate, isopropyl myristate, myristyl myristate, hexadecyl myristate, 2-hexyldecyl myristate, octyldodecyl myristate, isopropyl palmitate, ethylhexyl palmitate, hexadecyl palmitate, 2-hexyldecyl palmitate, 2-heptylundecyl palmitate, butyl stearate, 2-ethylhexyl stearate, isocetyl stearate, isocetyl isostearate, isononyl isononanoate, and isotridecyl isononanoate.

[0042] (ii) Examples of fatty acid diesters composed of fatty acids and dihydric alcohols include diesters of saturated fatty acids having from 8 to 22 carbon atoms and aliphatic or aromatic dihydric alcohols having from 1 to 12 carbon atoms, such as ethylene glycol di-2-ethylhexanoate, ethylene glycol dilaurate, ethylene glycol distearate, neopentyl glycol dicaprate, neopentyl glycol diethylhexanoate, propanediol di(caprylate / caprate), and propanediol diisostearate.

[0043] (iii) Examples of dicarboxylic acid diesters composed of dicarboxylic acids and monohydric alcohols include diesters of aliphatic or aromatic dicarboxylic acids having from 4 to 18 carbon atoms and aliphatic or aromatic ring-containing monohydric alcohols having from 1 to 24 carbon atoms, such as 2-ethylhexyl succinate, dibutyl adipate, diisobutyl adipate, 2-hexyldecyl adipate, di-2-heptylundecyl adipate, diethyl sebacate, diisopropyl sebacate, di-2-ethylhexyl sebacate, and diisononyl phthalate.

[0044] (iv) Examples of tricarboxylic acid triesters composed of tricarboxylic acids and monohydric alcohols include triesters of aliphatic or aromatic tricarboxylic acids having from 5 to 12 carbon atoms and aliphatic or aromatic ring-containing monohydric alcohols having from 1 to 24 carbon atoms, such as triisodecyl trimellitate.

[0045] Furthermore, (v) glycerin fatty acid triesters include triesters of glycerin and saturated fatty acids having from 8 to 22 carbon atoms, such as glycerin tri-2-ethylhexanoate, glycerin trimyristate, glycerin tri-2-heptylundecanoate, and tristearin.

[0046] Other ester oils that can be used besides the above (i) to (v) include alkyl benzoate, hexyldecyl dimethyloctanoate, cetyl lactate, myristyl lactate, lanolin acetate, dipentaerythritol fatty acid esters, diisostearyl malate, glycerin di-2-heptylundecanoate, castor oil fatty acid methyl esters, 2-octyldodecyl N-lauroyl-L-glutamate, and 2-hexyldecyl adipate.

[0047] Among the above, the ester oil is more preferably at least one selected from the group consisting of (i) fatty acid monoesters formed from fatty acids and monohydric alcohols, and (iii) dicarboxylic acid diesters formed from dicarboxylic acids and monohydric alcohols, even more preferably at least one selected from the group consisting of fatty acid monoesters formed from fatty acids and monohydric alcohols having 1 to 24 carbon atoms, and dicarboxylic acid diesters formed from dicarboxylic acids having 4 to 18 carbon atoms and monohydric alcohols having 1 to 24 carbon atoms, and even more preferably at least one selected from the group consisting of isopropyl myristate, dibutyl adipate, diethyl sebacate, and diisopropyl sebacate.

[0048] Specific examples of non-polar oils include non-volatile hydrocarbon oils, silicone oils, fluorine oils, etc. Examples of the hydrocarbon oils include liquid paraffin and squalane, examples of the silicone oils include dimethylpolysiloxane, dimethylcyclopolysiloxane, methylphenylpolysiloxane, methylhydrogenpolysiloxane, and higher alcohol-modified organopolysiloxane, and examples of the fluorine oils include fluoropolyether and perfluoroalkyl ether silicone.

[0049] The hydrophilic base is preferably at least one selected from the group consisting of polyols and lower amines. Specific examples of polyols include non-volatile alkylene glycols, polyalkylene glycols, glycerins, etc. Examples of the alkylene glycols include ethylene glycol, propylene glycol, 1,3-propanediol, 1,3-butylene glycol (1,3-butanediol), 1,2-pentanediol, etc. Examples of the polyalkylene glycols include diethylene glycol, dipropylene glycol, polyethylene glycol, polypropylene glycol, polyoxyethylene-polyoxypropylene glycol, etc. Examples of the glycerins include glycerin, diglycerin, triglycerin, etc. The polyethylene glycol, polypropylene glycol, and polyoxyethylene-polyoxypropylene glycol preferably have a weight-average molecular weight of 10,000 or less.

[0050] As used herein, the term "lower amine" refers preferably to an amine having 9 or fewer carbon atoms, more preferably 2 to 9 carbon atoms. The lower amine is preferably an alkanolamine from the viewpoints of nonvolatility, improving the film-forming properties, skin application properties, and quick-drying properties of the composition, and enhancing the sustained release of component (A) onto the skin. Specific examples of alkanolamines include triethanolamine, diethanolamine, monoethanolamine, triisopropanolamine, diisopropanolamine, monoisopropanolamine, and 2-amino-2-methylpropanol.

[0051] One or more types of component (C) can be used. Among the above, component (C) is preferably one or more selected from the group consisting of ester oils, non-polar oils, polyols, and alkanolamines, more preferably one or more selected from the group consisting of isopropyl myristate, dibutyl adipate, diethyl sebacate, diisopropyl sebacate, propylene glycol, 1,3-butylene glycol, 1,2-pentanediol, dipropylene glycol, polyethylene glycol, polypropylene glycol, polyoxyethylene-polyoxypropylene glycol, glycerin, diglycerin, triethanolamine, monoethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, and even more preferably one or more selected from the group consisting of isopropyl myristate, diethyl sebacate, triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol.

[0052] <Component (D): Volatile solvent> The composition of the present invention contains a volatile solvent (excluding those corresponding to component (A)) as component (D). Component (D) contributes to improving the application properties, quick-drying properties, storage stability, etc. of the composition. The "volatile solvent" of component (D) is as defined above.

[0053] Examples of the component (D) include volatile alcohols, ketones, esters, hydrocarbons, silicones, and the like. The alcohol used as component (D) is preferably a lower alcohol. The "lower alcohol" preferably refers to a monohydric alcohol having four or fewer carbon atoms, such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, sec-butyl alcohol, and tert-butyl alcohol. Examples of ketones that can be used as component (D) include acetone, ethyl methyl ketone, and methyl isobutyl ketone; examples of esters include methyl acetate, ethyl acetate, and butyl acetate; examples of hydrocarbons include volatile liquid paraffin; and examples of silicones include linear polydimethylsiloxanes and cyclic siloxanes.

[0054] The component (D) can be used alone or in combination of two or more. From the viewpoint of improving the coatability and quick-drying properties of the composition, the solubility or dispersibility of components (A) to (C), and the storage stability of the composition, component (D) is preferably a lower alcohol, and more preferably at least one selected from the group consisting of ethanol and isopropyl alcohol.

[0055] <Component (E): Water> The composition of the present invention contains water as component (E), which contributes to improving storage stability and other properties. There are no particular limitations on the component (E), and examples that can be used include ion-exchanged water, pure water, and distilled water.

[0056] <Other ingredients> In addition to the above-mentioned components, the topical composition of the present invention may contain other components that are typically incorporated into topical compositions, as appropriate, provided that the purpose of the present invention is not impaired. Examples of such components include surfactants, water-soluble polymers, antioxidants, UV absorbers, vitamins, preservatives, pH adjusters, fragrances, plant extracts other than component (A), moisturizers, colorants, cooling agents, antiperspirants, and skin activators.

[0057] <Content> The content of each component in the topical preparation composition of the present invention is preferably as follows, from the viewpoint of obtaining a topical preparation composition that can sustainably release the medicinal component onto the skin, has good film-forming properties, is easy to apply to the skin, dries quickly, and is excellent in suppressing the stickiness and tightness of the formed film, and in improving the appearance, durability, etc.

[0058] The content of component (A) in the composition is preferably 0.001% by mass or more, more preferably 0.005% by mass or more, even more preferably 0.01% by mass or more, still more preferably 0.1% by mass or more, and even more preferably 1.0% by mass or more, from the viewpoint of ensuring sufficient efficacy as a medicinal ingredient, and is preferably 30% by mass or less, more preferably 20% by mass or less, even more preferably 15% by mass or less, still more preferably 10% by mass or less, and even more preferably 5.0% by mass or less, from the viewpoint of improving the storage stability of the composition. The content of component (A) in the composition is preferably 0.001% by mass or more and 30% by mass or less, more preferably 0.005% by mass or more and 20% by mass or less, even more preferably 0.01% by mass or more and 15% by mass or more, still more preferably 0.1% by mass or more and 10% by mass or less, and even more preferably 1.0% by mass or more and 5.0% by mass or less.

[0059] When component (A) contains glycol salicylate, the content of glycol salicylate in the composition is preferably 0.1% by mass or more and 30% by mass or less, more preferably 0.5% by mass or more and 20% by mass or less, even more preferably 1.0% by mass or more and 15% by mass or less, even more preferably 2.0% by mass or more and 12% by mass or less, and even more preferably 2.0% by mass or more and 5.0% by mass or less. When component (A) contains loxoprofen sodium, the content of loxoprofen sodium in the composition is preferably 0.01% by mass or more and 20% by mass or less, more preferably 0.05% by mass or more and 10% by mass or less, and even more preferably 0.1% by mass or more and 5.0% by mass or less. When component (A) contains felbinac, the content of felbinac in the composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.1% by mass or more and 20% by mass or less, even more preferably 0.5% by mass or more and 15% by mass or less, still more preferably 1.0% by mass or more and 10% by mass or less, and even more preferably 1.5% by mass or more and 5.0% by mass or less. When component (A) contains 1-menthol, the content of 1-menthol in the composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.1% by mass or more and 20% by mass or less, and still more preferably 0.5% by mass or more and 10% by mass or less. When component (A) contains nonylic acid vanillylamide, the content of nonylic acid vanillylamide in the composition is preferably 0.001% by mass or more and 15% by mass or less, more preferably 0.005% by mass or more and 10% by mass or less, even more preferably 0.01% by mass or more and 5.0% by mass or less, even more preferably 0.01% by mass or more and 1.0% by mass or less, and even more preferably 0.01% by mass or more and 0.1% by mass or less.

[0060] From the viewpoints of film-forming ability and film durability, the content of component (B) in the composition is preferably 0.01% by mass or more, more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, still more preferably 0.5% by mass or more, and even more preferably 1.0% by mass or more, and from the viewpoints of improving the coatability and quick-drying properties of the composition, it is preferably 30% by mass or less, more preferably 25% by mass or less, even more preferably 20% by mass or less, still more preferably 12% by mass or less, and even more preferably 5.0% by mass or less. The content of component (B) in the composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.05% by mass or more and 25% by mass or less, even more preferably 0.1% by mass or more and 20% by mass or less, still more preferably 0.5% by mass or more and 12% by mass or less, and even more preferably 1.0% by mass or more and 5.0% by mass or less.

[0061] When component (B) contains an (acrylates / diacetone acrylamide) copolymer, the content of the copolymer in the composition is even more preferably 0.1% by mass or more and 15% by mass or less, even more preferably 0.5% by mass or more and 10% by mass or less, and even more preferably 1.5% by mass or more and 5.0% by mass or less. When component (B) contains an acrylamide-methoxypolyethylene glycol methacrylate copolymer, the content of the copolymer in the composition is even more preferably 0.1% by mass or more and 10% by mass or less. When component (B) contains ethyl cellulose, the content of ethyl cellulose in the composition is even more preferably 0.1% by mass to 20% by mass. When component (B) contains hypromellose phthalate, the content of hypromellose phthalate in the composition is even more preferably 0.1% by mass to 20% by mass, even more preferably 0.5% by mass to 15% by mass, even more preferably 1.0% by mass to 10.0% by mass, and even more preferably 1.5% by mass to 5.0% by mass. When component (B) contains polyvinyl butyral, the content of polyvinyl butyral in the composition is even more preferably 0.1% by mass to 20% by mass.

[0062] The content of component (C) in the composition is preferably 0.001% by mass or more, more preferably 0.005% by mass or more, even more preferably 0.01% by mass or more, even more preferably 0.1% by mass or more, and even more preferably 1.0% by mass or more, from the viewpoint of improving the sustained release of component (A) to the skin and suppressing the tight feeling of the coating that is formed; and is preferably 30% by mass or less, more preferably 20% by mass or less, even more preferably 10% by mass or less, still more preferably 8.0% by mass or less, and even more preferably 5.0% by mass or less, from the viewpoint of suppressing stickiness of the coating that is formed and improving abrasion resistance. The content of component (C) in the composition is preferably 0.001% by mass or more and 30% by mass or less, more preferably 0.005% by mass or more and 20% by mass or less, even more preferably 0.1% by mass or more and 15% by mass or less, even more preferably 0.01% by mass or more and 10% by mass or less, even more preferably 0.1% by mass or more and 8.0% by mass or less, and even more preferably 1.0% by mass or more and 5.0% by mass or less.

[0063] When component (C) contains isopropyl myristate, the content of isopropyl myristate in the composition is even more preferably 0.1% by mass or more and 10% by mass or less, even more preferably 0.25% by mass or more and 7.5% by mass or less, and even more preferably 0.5% by mass or more and 5.0% by mass or less; when component (C) contains diethyl sebacate, the content of diethyl sebacate in the composition is even more preferably 0.1% by mass or more and 10% by mass or less, even more preferably 0.25% by mass or more and 7.5% by mass or less, and even more preferably 0.5% by mass or more and 5.0% by mass or less. When component (C) contains diisopropanolamine, the content of diisopropanolamine in the composition is even more preferably 0.1 to 5.0% by mass, even more preferably 0.5 to 4.0% by mass, and even more preferably 1.0 to 3.0% by mass; when component (C) contains triethanolamine, the content of triethanolamine in the composition is even more preferably 0.1 to 5.0% by mass, and even more preferably 1.0 to 3.0% by mass; and when component (C) contains 2-amino-2-methylpropanol, the content of 2-amino-2-methylpropanol in the composition is even more preferably 0.01 to 3.0% by mass.

[0064] The content of component (D) in the composition is preferably 10% by mass or more, more preferably 25% by mass or more, even more preferably 45% by mass or more, and even more preferably 65% ​​by mass or more from the viewpoints of improving the coatability and quick-drying properties of the composition and improving storage stability, and is preferably 95% by mass or less, more preferably 90% by mass or less, even more preferably 80% by mass or less, and even more preferably 75% by mass or less from the viewpoints of maintaining the coatability and film-forming properties of the composition. The content of component (D) in the composition is preferably 10% by mass or more and 95% by mass or less, more preferably 25% by mass or more and 90% by mass or less, even more preferably 45% by mass or more and 80% by mass or less, and even more preferably 65% ​​by mass or more and 75% by mass or less. When ethanol is contained as component (D), the content of ethanol in the composition is even more preferably 30% by mass to 90% by mass, even more preferably 30% by mass to 75% by mass, and even more preferably 45% by mass to 75% by mass. When isopropyl alcohol is contained as component (D), the content of isopropyl alcohol in the composition is even more preferably 30% by mass to 90% by mass, even more preferably 30% by mass to 75% by mass, and even more preferably 45% by mass to 75% by mass.

[0065] Furthermore, from the viewpoints of improving the coatability and storage stability of the composition and maintaining film-forming properties, the content of component (E) in the composition is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, even more preferably 5% by mass or more, and still more preferably 13% by mass or more; and from the viewpoints of improving the coatability and storage stability of the composition, maintaining the quick-drying properties of the composition, improving storage stability, and maintaining a good appearance during low-temperature storage, the content of component (E) in the composition is preferably 70% by mass or less, more preferably 50% by mass or less, even more preferably 30% by mass or less, still more preferably 25% by mass or less, still more preferably 22% by mass or less, still more preferably 21% by mass or less, and still more preferably 20% by mass or less. The content of component (E) in the composition is preferably 0.1% by mass or more and 70% by mass or less, more preferably 0.5% by mass or more and 50% by mass or less, even more preferably 0.5% by mass or more and 30% by mass or less, still more preferably 0.5% by mass or more and 25% by mass or less, even more preferably 0.5% by mass or more and 22% by mass or less, still more preferably 5% by mass or more and 22% by mass or less, still more preferably 5% by mass or more and 21% by mass or less, and still more preferably 13% by mass or more and 20% by mass or less. The content of component (E) in the composition may be more than 30% by mass and not more than 70% by mass from the viewpoints of improving the coatability and storage stability of the composition, maintaining film-forming properties, and maintaining a good appearance during low-temperature storage.

[0066] From the viewpoint of obtaining the effects of the present invention, the total content of components (A) to (E) in the composition is preferably 50% by mass or more, more preferably 70% by mass or more, even more preferably 80% by mass or more, and even more preferably 90% by mass or more, and is 100% by mass or less.

[0067] The mass ratio of component (A) to component (B) in the composition [(A) / (B)] is preferably 0.01 or more, more preferably 0.02 or more, even more preferably 0.03 or more, still more preferably 0.05 or more, still more preferably 0.10 or more, and still more preferably 0.15 or more, from the viewpoint of improving the sustained release of component (A) to the skin, and is preferably 50 or less, more preferably 30 or less, even more preferably 20 or less, still more preferably 10 or less, still more preferably 5.0 or less, and still more preferably 3.0 or less, from the viewpoint of improving the application property, storage stability, film-forming property, and film durability of the composition. The mass ratio [(A) / (B)] in the composition is preferably 0.01 or more and 50 or less, more preferably 0.02 or more and 30 or less, even more preferably 0.03 or more and 20 or less, still more preferably 0.05 or more and 10 or less, still more preferably 0.10 or more and 5.0 or less, and still more preferably 0.15 or more and 3.0 or less.

[0068] The mass ratio of component (A) to component (C) in the composition [(A) / (C)] is preferably 0.01 or more, more preferably 0.02 or more, even more preferably 0.03 or more, still more preferably 0.05 or more, still more preferably 0.10 or more, and still more preferably 0.15 or more, from the viewpoint of improving the sustained release of component (A) to the skin and the storage stability of the composition; and is preferably 10 or less, more preferably 5.0 or less, even more preferably 3.0 or less, still more preferably 2.5 or less, still more preferably 2.0 or less, and still more preferably 1.5 or less, from the viewpoint of improving the applyability and storage stability of the composition and the durability of the coating formed. The mass ratio [(A) / (C)] in the composition is preferably 0.01 or more and 10 or less, more preferably 0.02 or more and 5.0 or less, even more preferably 0.03 or more and 3.0 or less, still more preferably 0.05 or more and 2.5 or less, even more preferably 0.10 or more and 2.0 or less, and still more preferably 0.15 or more and 1.5 or less.

[0069] The mass ratio of component (C) to component (B) in the composition [(C) / (B)] is preferably 0.05 or more, more preferably 0.10 or more, even more preferably 0.20 or more, and even more preferably 0.50 or more, from the viewpoint of improving the sustained release of component (A) to the skin and improving film-forming properties, and from the viewpoint of the durability of the formed film, it is preferably 50 or less, more preferably 35 or less, even more preferably 20 or less, even more preferably 10 or less, even more preferably 5.0 or less, and even more preferably 3.5 or less. The mass ratio [(C) / (B)] in the composition is preferably 0.05 or more and 50 or less, more preferably 0.10 or more and 35 or less, even more preferably 0.20 or more and 20 or less, even more preferably 0.20 or more and 10 or less, even more preferably 0.20 or more and 5.0 or less, even more preferably 0.50 or more and 5.0 or less, and even more preferably 0.50 or more and 3.5 or less. Alternatively, the mass ratio [(C) / (B)] in the composition is preferably 0.05 or more and 50 or less, more preferably 0.05 or more and 35 or less, even more preferably 0.05 or more and 20 or less, still more preferably 0.05 or more and 10 or less, even more preferably 0.05 or more and 5.0 or less, still more preferably 0.05 or more and 5.0 or less, and still more preferably 0.05 or more and 3.5 or less.

[0070] The mass ratio of component (E) to component (D) in the composition [(E) / (D)] is preferably 0.005 or more, more preferably 0.05 or more, even more preferably 0.10 or more, still more preferably 0.16 or more, and even more preferably 0.20 or more from the viewpoint of improving the coatability, quick-drying properties, and storage stability of the composition, and from the same viewpoint, is preferably 3.0 or less, more preferably 2.0 or less, even more preferably 1.0 or less, still more preferably 0.80 or less, and even more preferably 0.40 or less. The mass ratio [(E) / (D)] in the composition is preferably 0.005 or more and 3.0 or less, more preferably 0.05 or more and 2.0 or less, even more preferably 0.10 or more and 1.0 or less, still more preferably 0.16 or more and 0.80 or less, and even more preferably 0.20 or more and 0.40 or less.

[0071] The mass ratio of component (B) to the total content of components (D) and (E) in the composition [(B) / {(D)+(E)}] is preferably 0.001 or more, more preferably 0.01 or more, and even more preferably 0.02 or more from the viewpoint of improving film-forming ability, and is preferably 1.0 or less, more preferably 0.50 or less, even more preferably 0.20 or less, still more preferably 0.12 or less, and even more preferably 0.10 or less from the viewpoint of improving coatability and quick-drying ability. The mass ratio [(B) / {(D)+(E)}] in the composition is preferably 0.001 or more and 1.0 or less, more preferably 0.01 or more and 0.50 or less, even more preferably 0.01 or more and 0.20 or less, still more preferably 0.01 or more and 0.12 or less, and even more preferably 0.02 or more and 0.10 or less.

[0072] The mass ratio of component (A) to the total amount of component (B) and component (C) in the composition [(A) / {(B)+(C)}] is preferably 0.001 or more, more preferably 0.005 or more, even more preferably 0.01 or more, still more preferably 0.05 or more, and still more preferably 0.10 or more, from the viewpoint of ensuring sufficient effect as a medicinal ingredient and improving the sustained release of component (A) into the skin; and is preferably 5.00 or less, more preferably 3.00 or less, even more preferably 2.50 or less, still more preferably 2.40 or less, still more preferably 2.00 or less, still more preferably 1.60 or less, still more preferably 1.00 or less, and still more preferably 0.60 or less, from the viewpoint of suppressing crystallization of component (A), from the viewpoint of durability of the coating film formed, and from the viewpoint of improving the storage stability of the composition. The mass ratio [(A) / {(B)+(C)}] in the composition is preferably 0.001 to 5.00, more preferably 0.005 to 3.00, even more preferably 0.01 to 2.50, still more preferably 0.05 to 2.50, even more preferably 0.10 to 2.50, still more preferably 0.10 to 1.60, still more preferably 0.10 to 1.00, and still more preferably 0.10 to 0.60. In particular, from the viewpoint of suppressing crystallization of component (A), it is preferably 0.001 to 2.40, more preferably 0.005 to 2.00, even more preferably 0.01 to 1.60, still more preferably 0.05 to 1.00, and still more preferably 0.05 to 0.60.

[0073] <Viscosity> The viscosity of the topical composition of the present invention at 25°C is 1.0 mPa·s or more, preferably 3.0 mPa·s or more, more preferably 5.0 mPa·s or more, and even more preferably 10.0 mPa·s or more, from the viewpoints of improving the ease of application to skin and the uniformity of the coating formed. Also, from the viewpoints of improving the quick-drying properties of the composition and the appearance of the coating formed, the viscosity is 10,000 mPa·s or less, preferably 7,500 mPa·s or less, more preferably 5,000 mPa·s or less, even more preferably 3,000 mPa·s or less, still more preferably 2,000 mPa·s or less, even more preferably 1,000 mPa·s or less, and even more preferably 700 mPa·s or less. The viscosity of the topical composition at 25°C is from 1.0 mPa·s to 10,000 mPa·s, preferably from 3.0 mPa·s to 7,500 mPa·s, more preferably from 3.0 mPa·s to 5,000 mPa·s, even more preferably from 3.0 mPa·s to 3,000 mPa·s, still more preferably from 3.0 mPa·s to 2,000 mPa·s, even more preferably from 5.0 mPa·s to 1,000 mPa·s, and still more preferably from 10.0 mPa·s to 700 mPa·s. The viscosity of the topical composition at 25°C is a value measured using a vibration viscometer for compositions of 1,000 mPa·s or less, and a B-type rotational viscometer for compositions of more than 1,000 mPa·s. Specifically, the viscosity can be measured using the method described in the Examples.

[0074] <Δ(SP A -SP B+C )> Furthermore, in the composition of the present invention, from the viewpoint of improving the sustained release of component (A) onto the skin and improving the storage stability of the composition, the SP value (SP A ) and the SP value of the mixture of component (B) and component (C) (SP B+C ) and the absolute value of the difference [Δ(SP A -SP B+C)] is preferably 0.10 or more, more preferably 0.15 or more, even more preferably 0.20 or more, even more preferably 0.30 or more, and even more preferably 0.50 or more, and is preferably 10.00 or less, more preferably 8.00 or less, even more preferably 7.00 or less, and even more preferably 5.00 or less. A -SP B+C )] is preferably 0.10 or more and 10.00 or less, more preferably 0.15 or more and 8.00 or less, even more preferably 0.20 or more and 7.00 or less, still more preferably 0.30 or more and 5.00 or less, and more preferably 0.50 or more and 5.00 or less. [Δ(SP A -SP B+C If the ratio (R) is 0.10 or more, the compatibility between component (A) and the coating is not excessively high, the spinnability of the coating formed can be suppressed, and the sustained release of component (A) onto the skin side is maintained in a good condition. If the ratio (R) is 10.00 or less, the compatibility between component (A) and the coating is not excessively low, and the crystallization of the crystalline component (A) can be suppressed, and the sustained release of component (A) onto the skin side is maintained in a good condition. SP value of component (A) (SP A ), and the SP value of the mixture of component (B) and component (C) (SP B+C ) can be calculated in the same manner as above.

[0075] <Dosage form, etc.> The topical composition of the present invention is preferably used as a topical composition for skin. The topical preparation composition of the present invention may be in any dosage form as long as it has a viscosity within the above range and is applicable to the skin. Examples include lotion preparations, gel preparations, ointment preparations, cream preparations, and foam preparations comprising the topical preparation composition of the present invention; and aerosol preparations or pump spray preparations using the topical preparation composition of the present invention. Examples of foam preparations include preparations in which the topical preparation composition of the present invention is filled into a pump former or the like and discharged in the form of foam. The compositions of the present invention can also be electrostatically sprayed onto the skin using an electrostatic spray device, which is described below.

[0076] The aerosol formulation contains the topical composition and a propellant. The aerosol formulation using the topical composition of the present invention can provide a cooling sensation or the like by spraying the composition onto the skin. In the aerosol formulation, the topical composition used as an aerosol concentrate and its preferred embodiments are the same as those described above. That is, the contents and viscosity of components (A) to (E) in the aerosol concentrate are preferably within the above-mentioned ranges. Propellants used in aerosol formulations include liquefied petroleum gas (LPG), which is ethane, propane, normal butane, isobutane, isopentane, and mixtures thereof; ethers such as dimethyl ether; compressed gases such as nitrogen and carbon dioxide; and the like, and one or more of these can be used.

[0077] In the aerosol formulation, the ratio of the mass of the topical composition (aerosol concentrate) to the propellant is not particularly limited as long as it is possible to spray the topical composition onto the skin. From the viewpoint of aerosol performance and the stability of component (A), however, the mass ratio of the topical composition to the propellant is preferably in the range of 1:0.01 to 1:10, more preferably 1:0.05 to 1:7.5. When the propellant is LPG, the mass ratio of the topical preparation composition to LPG is more preferably 1:0.5 to 1:5; when the propellant is dimethyl ether, the mass ratio of the topical preparation composition to dimethyl ether is more preferably 1:0.1 to 1:5; and when the propellant is carbon dioxide, the mass ratio of the topical preparation composition to carbon dioxide is more preferably 1:0.1 to 1:0.5.

[0078] Examples of aerosol containers used for aerosol formulations include known pressure-resistant containers made of metal, plastic, etc., as well as double-structure containers in which an inner bag is housed inside a pressure-resistant container. In double-structure containers, it is preferred that the inner bag is filled with the topical preparation composition, which is an aerosol concentrate, and that the space between the pressure-resistant container and the inner bag is filled with a propellant.

[0079] The method for preparing the aerosol formulation is not particularly limited. For example, the aerosol formulation can be prepared by filling the aerosol container with the topical composition as an aerosol concentrate, attaching a valve, and then filling the propellant through the valve.

[0080] The pump spray formulation is a formulation in which the topical composition of the present invention is filled into a pump spray container for use.

[0081] [How to use] The present invention also provides a method for using the topical composition, which comprises the steps of applying the topical composition to the skin and then drying it. According to the method of the present invention, by applying the topical preparation composition to the skin and then drying it, a coating containing the active ingredient, component (A), can be formed on the skin surface. The coating has excellent moisture resistance and abrasion resistance, and is highly capable of sustained release of component (A) to the skin, allowing component (A) to be sustainedly released into the skin. Hereinafter, the process of applying the topical preparation composition to the skin and then drying it will also be referred to as the "coating formation process."

[0082] The method of applying the topical composition to the skin can be appropriately selected depending on the formulation of the topical composition, and examples include application by coating, casting, spraying, etc. Among these, application by coating or spraying is preferred. After application of the topical composition, component (D) volatilizes when the composition is dried by natural drying or the like, and a coating containing components (A) to (C) is formed on the skin surface.

[0083] In the method of the present invention, when the topical composition is applied by direct application to the skin, the topical composition can be applied by hand or using an applicator such as a metal roller, a plastic roller, a sponge-like porous body, or a brush. In the method of the present invention, when the topical composition is applied to the skin by spraying, the method of spraying the composition can be a method using an aerosol, a pump spray, or an electrostatic spray device. For aerosol and pump spray, the topical composition can be used as a stock solution to prepare the aerosol formulation or pump spray formulation, and the topical composition can be sprayed onto the skin using the formulation. Specifically, the electrostatic spray device comprises a storage section capable of storing the topical preparation composition, a nozzle for ejecting the topical preparation composition, a power source for applying a voltage to the nozzle, and means for delivering the topical preparation composition from the storage section to the nozzle. One embodiment of the electrostatic spray device is a handy electrostatic spray device that is sized to be held in one hand. As the electrostatic spray device, those exemplified in International Publication No. 2018 / 194140, etc. can be used.

[0084] The site to which the topical composition is applied is not particularly limited, but is preferably the skin surface of a body part, more preferably the skin surface of the hands, arms, feet, legs, or trunk.

[0085] The amount of the topical composition to be applied to the skin is not particularly limited, but from the viewpoint of sufficiently sustained release of component (A) onto the skin, it is preferably 0.5 μL / cm 2 More preferably, 1 μL / cm 2 More preferably, 3 μL / cm 2 In addition, from the viewpoint of the appearance (transparency) of the formed coating, it is preferable to use 100 μL / cm 2 or less, more preferably 50 μL / cm 2 The following is the result.

[0086] [Coating manufacturing method] The present invention also provides a method for producing a coating, which comprises the step of applying the topical composition to the skin by directly applying or spraying it onto the skin. When the topical composition is applied by direct application to the skin, the topical composition can be applied by hand or with an applicator such as a metal roller, as described above. When the topical composition is applied by spraying it directly onto the skin, the method for spraying the composition includes the use of an aerosol, pump spray, or electrostatic spray device.

[0087] An embodiment of a method for producing a coating when applying an external preparation composition to the skin by electrostatic spraying using an external preparation composition and an electrostatic spray device will be described below. First, the storage compartment of the handy electrostatic spray device is filled with the topical composition, and the user, i.e., the person who forms a coating on the application site on the skin by electrostatic spray, holds the device in his / her hand and points one end of the device, where the nozzle is located, toward the application site where electrostatic spraying will be performed. Under these conditions, the electrostatic spraying method can be performed by turning on the electrostatic spray device. When the device is turned on, an electric field is generated between the nozzle and the skin, a positive high voltage is applied to the nozzle, and the skin becomes the negative electrode. When an electric field is generated between the nozzle and the skin, the topical composition at the tip of the nozzle is polarized by electrostatic induction, forming a cone-shaped tip. Charged droplets of the topical composition are ejected from the tip of the cone into the air along the electric field toward the skin. As the volatile solvent (component (D)) evaporates from the charged topical composition ejected into space, the charge density on the surface of the topical composition becomes excessive, causing the particles to repeatedly break down into small particles due to Coulomb repulsion, spreading into space and reaching the skin. In this case, by appropriately adjusting the viscosity of the topical composition, the amount of volatile solvent, the type and amount of polymer, the flow rate, the voltage, and the like, the sprayed composition can be made to reach the application site in the form of droplets. Preferably, component (D) is evaporated from the droplets while being discharged into the space, and component (B), the main film-forming component, is solidified while being stretched and deformed by the potential difference to form fibers, which can then be deposited on the application site, forming a porous film consisting of the fiber deposit on the surface of the application site.

[0088] In addition to the above-described embodiments, the present invention also discloses the following embodiments. <1> An external application composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity at 25°C of 1.0 mPa·s or more, preferably 3.0 mPa·s or more, more preferably 5.0 mPa·s or more, and even more preferably 10.0 mPa·s or more, and 10,000 mPa·s or less, preferably 7,500 mPa·s or less, more preferably 5,000 mPa·s or less, even more preferably 3,000 mPa·s or less, still more preferably 2,000 mPa·s or less, still more preferably 1,000 mPa·s or less, and even more preferably 700 mPa·s or less. <2> An external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (E) in the external preparation composition is 0.1% by mass or more and 30% by mass or less, the mass ratio of component (A) to the total amount of components (B) and (C) [(A) / {(B)+(C)}] is 0.001 or more and 2.40 or less, and the viscosity at 25°C is 1.0 mPa·s or more and 10,000 mPa·s or less. <3> An external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (E) in the external preparation composition is more than 30% by mass and not more than 70% by mass, the mass ratio of component (A) to the total amount of components (B) and (C) [(A) / {(B)+(C)}] is 0.001 or more and 2.40 or less, and the viscosity at 25°C is 1.0 mPa s or more and 10,000 mPa s or less. <4> An external preparation composition comprising (A) an anti-inflammatory and analgesic ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (B) in the external preparation composition is 0.1% by mass or more and 15% by mass or less, the mass ratio of component (C) to component (B) in the external preparation composition [(C) / (B)] is 0.05 or more and 3.5 or less, and the viscosity at 25°C is 1.0 mPa s or more and 10,000 mPa s or less. <5> An external preparation composition containing (A) one or more medicinal ingredients selected from the group consisting of glycol salicylate, diclofenac sodium, loxoprofen sodium, felbinac, indomethacin, piroxicam, flurbiprofen, methyl salicylate, ketoprofen, and vanillyl nonylate amide, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (C) in the external preparation composition is 5.0% by mass or less, and the viscosity at 25°C is 1.0 mPa·s or more and 10,000 mPa·s or less. <6> The viscosity of the topical composition at 25°C is preferably 3.0 mPa·s or more, more preferably 5.0 mPa·s or more, even more preferably 10.0 mPa·s or more, and is preferably 7,500 mPa·s or less, more preferably 5,000 mPa·s or less, even more preferably 3,000 mPa·s or less, still more preferably 2,000 mPa·s or less, still more preferably 1,000 mPa·s or less, and still more preferably 700 mPa·s or less. <2> ~ <5> The topical composition according to any one of the above. <7> The SP value of component (B) is preferably 17.00 or more, more preferably 18.00 or more, even more preferably 19.00 or more, still more preferably 20.00 or more, and is preferably 27.00 or less, more preferably 25.00 or less, even more preferably 24.00 or less, and still more preferably 23.00 or less. <1> ~ <6> The topical composition according to any one of the above. <8> SP value of component (A) (SP A ) and the SP value of the mixture of component (B) and component (C) (SP B+C ) and the absolute value of the difference [Δ(SP A -SP B+C)] is preferably 0.10 or more, more preferably 0.15 or more, even more preferably 0.20 or more, still more preferably 0.30 or more, still more preferably 0.50 or more, and is preferably 10.00 or less, more preferably 8.00 or less, still more preferably 7.00 or less, still more preferably 5.00 or less, <1> ~ <7> The topical composition according to any one of the above. <9> Component (A) comprises one or more selected from the group consisting of anti-inflammatory and analgesic components, local stimulating components, blood circulation promoting components, antihistamine components, herbal ingredients, antipruritic components, local anesthetic components, keratin softening components, bactericidal components, and antibacterial components, preferably one or more selected from the group consisting of anti-inflammatory and analgesic components, local stimulating components, blood circulation promoting components, antihistamine components, and herbal ingredients, more preferably one or more selected from the group consisting of anti-inflammatory and analgesic components and local stimulating components, <1> ~ <3> , <6> ~ <8> The topical composition according to any one of the above. <10> the component (A) comprises one or more selected from the group consisting of glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium, ketoprofen, felbinac, indomethacin, piroxicam, flurbiprofen, glycyrrhizic acid, glycyrrhetinic acid, l-menthol, dl-camphor, nonylic acid vanillylamide, peppermint oil, benzyl nicotinate, sodium polyethylene sulfonate, tocopherol acetate, diphenhydramine, chlorpheniramine maleate, capsicum, eucalyptus oil, and Phellodendron bark, and preferably comprises one or more selected from the group consisting of glycol salicylate, loxoprofen sodium, felbinac, l-menthol, and nonylic acid vanillylamide; <1> ~ <3> , <6> ~ <9> The topical composition according to any one of the above. <11> The SP value of component (A) is preferably 15.00 or more, more preferably 18.00 or more, even more preferably 19.00 or more, still more preferably 19.50 or more, and is preferably 35.00 or less, more preferably 27.00 or less, even more preferably 24.00 or less, still more preferably 22.00 or less. <1> ~ <10> The topical composition according to any one of the above. <12> Component (B) is a film-forming water-insoluble polymer, preferably one or more water-insoluble polymers selected from the group consisting of acrylic polymers, cellulose polymers, and vinyl polymers. <1> ~ <11> The topical composition according to any one of the above. <13> The acrylic polymer contains at least a structural unit derived from a monomer having a (meth)acrylic group, and is selected from the group consisting of (acrylates / diacetoneacrylamide) copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, acrylic acid-octyl acrylate copolymer, acrylic acid ester-vinyl acetate copolymer, 2-ethylhexyl acrylate-methyl acrylate-acrylic acid-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-vinyl acetate-hydroxyethyl acrylate ... the copolymer is at least one selected from the group consisting of 2-ethylhexyl acrylate-diacetoneacrylamide-acetoacetoxyethyl methacrylate-methyl methacrylate copolymer, 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, ethyl acrylate-methyl methacrylate copolymer, ethyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate chloride copolymer, and methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, <12> The topical composition according to claim 1. <14> The cellulose-based polymer is one or more selected from the group consisting of methyl cellulose, ethyl cellulose, hypromellose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, and hydrophobized (C16-18) hydroxypropyl methylcellulose. <12> The topical composition according to claim 1. <15> The vinyl polymer is at least one selected from the group consisting of polyvinyl alcohol and polyvinyl butyral. <12> The topical composition according to claim 1. <16> Component (B) is (acrylates / diacetoneacrylamide) copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, acrylic acid-octyl acrylate copolymer, acrylic acid ester-vinyl acetate copolymer, 2-ethylhexyl acrylate-methyl acrylate-acrylic acid-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-vinyl acetate-hydroxyethyl acrylate-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-diacetoneacrylamide-acetoacetoxyethyl methacrylate-methyl methacrylate copolymer, 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, ethyl acrylate-methyl methacrylate copolymer , one or more selected from the group consisting of ethyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate copolymer, methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, methyl cellulose, ethyl cellulose, hypromellose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, hydrophobized (C16-18) hydroxypropyl methylcellulose, polyvinyl alcohol, and polyvinyl butyral, preferably one or more selected from the group consisting of acrylates / diacetone acrylamide copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, ethyl cellulose, hypromellose phthalate, and polyvinyl butyral, <1> ~ <15> The topical composition according to any one of the above.

[0089] <17> Component (C) is at least one selected from the group consisting of lipophilic bases, hydrophilic bases, and amphiphilic bases, preferably at least one selected from the group consisting of lipophilic bases and hydrophilic bases. <1> ~ <16> The topical composition according to any one of the above. <18> The content of the non-volatile base containing an unsaturated hydrocarbon chain having 16 or more carbon atoms in component (C) is preferably 30% by mass or less, more preferably 10% by mass or less, even more preferably 5% by mass or less, still more preferably 1% by mass or less, and even more preferably 0% by mass. <1> ~ <17> The topical composition according to any one of the above. <19> Component (C) is one or more selected from the group consisting of ester oils, non-polar oils, polyols, and alkanolamines. <1> ~ <18> The topical composition according to any one of the above. <20> The ester oil is at least one selected from the group consisting of (i) a fatty acid monoester composed of a fatty acid and a monohydric alcohol, (ii) a fatty acid diester composed of a fatty acid and a dihydric alcohol, (iii) a dicarboxylic acid diester composed of a dicarboxylic acid and a monohydric alcohol, (iv) a tricarboxylic acid triester composed of a tricarboxylic acid and a monohydric alcohol, and (v) a glycerin fatty acid triester, preferably at least one selected from the group consisting of (i) a fatty acid monoester composed of a fatty acid and a monohydric alcohol, and (iii) a dicarboxylic acid diester composed of a dicarboxylic acid and a monohydric alcohol, more preferably at least one selected from the group consisting of a fatty acid monoester composed of a fatty acid and a monohydric alcohol having 1 to 24 carbon atoms, and a dicarboxylic acid diester composed of a dicarboxylic acid having 4 to 18 carbon atoms and a monohydric alcohol having 1 to 24 carbon atoms, and even more preferably at least one selected from the group consisting of isopropyl myristate, dibutyl adipate, diethyl sebacate, and diisopropyl sebacate. <19> The topical composition according to claim 1. <21> The non-polar oil is at least one selected from the group consisting of hydrocarbon oils, silicone oils, and fluorine oils, preferably at least one selected from the group consisting of liquid paraffin, squalane, dimethylpolysiloxane, dimethylcyclopolysiloxane, methylphenylpolysiloxane, methylhydrogenpolysiloxane, higher alcohol-modified organopolysiloxane, fluoropolyether, and perfluoroalkyl ether silicone. <19> The topical composition according to claim 1. <22> The polyol is at least one selected from the group consisting of alkylene glycols, polyalkylene glycols, and glycerins, preferably at least one selected from the group consisting of ethylene glycol, propylene glycol, 1,3-propanediol, 1,3-butylene glycol (1,3-butanediol), 1,2-pentanediol, diethylene glycol, dipropylene glycol, polyethylene glycol, polypropylene glycol, polyoxyethylene-polyoxypropylene glycol, glycerin, diglycerin, and triglycerin; <19> The topical composition according to claim 1. <23> The alkanolamine is preferably an alkanolamine having 9 or less carbon atoms, more preferably an alkanolamine having from 2 to 9 carbon atoms, and more preferably at least one selected from the group consisting of triethanolamine, diethanolamine, monoethanolamine, triisopropanolamine, diisopropanolamine, monoisopropanolamine, and 2-amino-2-methylpropanol. <19> The topical composition according to claim 1. <24> Component (C) is one or more selected from the group consisting of isopropyl myristate, dibutyl adipate, diethyl sebacate, diisopropyl sebacate, propylene glycol, 1,3-butylene glycol, 1,2-pentanediol, dipropylene glycol, polyethylene glycol, polypropylene glycol, polyoxyethylene-polyoxypropylene glycol, glycerin, diglycerin, triethanolamine, monoethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, preferably one or more selected from the group consisting of isopropyl myristate, diethyl sebacate, triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, <1> ~ <23> The topical composition according to any one of the above. <25> Component (D) is at least one selected from the group consisting of alcohols, ketones, esters, hydrocarbons, and silicones, preferably lower alcohols, more preferably at least one selected from the group consisting of methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, sec-butyl alcohol, and tert-butyl alcohol, and even more preferably at least one selected from the group consisting of ethanol and isopropyl alcohol; <1> ~ <24> The topical composition according to any one of the above.

[0090] <26> The content of component (A) in the topical preparation composition is preferably 0.001% by mass or more, more preferably 0.005% by mass or more, even more preferably 0.01% by mass or more, still more preferably 0.1% by mass or more, still more preferably 1.0% by mass or more, and is preferably 30% by mass or less, more preferably 20% by mass or less, even more preferably 15% by mass or less, still more preferably 10% by mass or less, and still more preferably 5.0% by mass or less. <1> ~ <25> The topical composition according to any one of the above. <27> The content of component (B) in the topical preparation composition is preferably 0.01% by mass or more, more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, even more preferably 0.5% by mass or more, even more preferably 1.0% by mass or more, and is preferably 30% by mass or less, more preferably 25% by mass or less, even more preferably 20% by mass or less, still more preferably 12% by mass or less, and even more preferably 5.0% by mass or less. <1> ~ <3> , <5> ~ <26> The topical composition according to any one of the above. <28> The content of component (C) in the topical preparation composition is preferably 0.001% by mass or more, more preferably 0.005% by mass or more, even more preferably 0.01% by mass or more, even more preferably 0.1% by mass or more, and even more preferably 1.0% by mass or more, and is preferably 30% by mass or less, more preferably 20% by mass or less, even more preferably 15% by mass or less, still more preferably 10% by mass or less, still more preferably 8.0% by mass or less, and even more preferably 5.0% by mass or less. <1> ~ <4> , <6> ~ <27> The topical composition according to any one of the above. <29> The content of component (D) in the topical preparation composition is preferably 10% by mass or more, more preferably 25% by mass or more, even more preferably 45% by mass or more, still more preferably 65% ​​by mass or more, and is preferably 95% by mass or less, more preferably 90% by mass or less, even more preferably 80% by mass or less, and still more preferably 75% by mass or less. <1> ~ <28> The topical composition according to any one of the above. <30> The content of component (E) in the topical preparation composition is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, even more preferably 5% by mass or more, still more preferably 13% by mass or more, and is preferably 70% by mass or less, more preferably 50% by mass or less, even more preferably 30% by mass or less, still more preferably 25% by mass or less, still more preferably 22% by mass or less, still more preferably 21% by mass or less, still more preferably 20% by mass or less. <1> , <4> ~ <29> The topical composition according to any one of the above. <31> The mass ratio of component (A) to component (B) in the topical composition [(A) / (B)] is preferably 0.01 or more, more preferably 0.02 or more, even more preferably 0.03 or more, still more preferably 0.05 or more, still more preferably 0.10 or more, still more preferably 0.15 or more, and is preferably 50 or less, more preferably 30 or less, even more preferably 20 or less, still more preferably 10 or less, still more preferably 5.0 or less, still more preferably 3.0 or less. <1> ~ <30> The topical composition according to any one of the above. <32> The mass ratio of component (A) to component (C) in the topical preparation composition [(A) / (C)] is preferably 0.01 or more, more preferably 0.02 or more, even more preferably 0.03 or more, still more preferably 0.05 or more, still more preferably 0.10 or more, still more preferably 0.15 or more, and is preferably 10 or less, more preferably 5.0 or less, even more preferably 3.0 or less, still more preferably 2.5 or less, still more preferably 2.0 or less, still more preferably 1.5 or less. <1> ~ <31> The topical composition according to any one of the above. <33> The mass ratio of component (C) to component (B) in the topical preparation composition [(C) / (B)] is preferably 0.05 or more, more preferably 0.10 or more, even more preferably 0.20 or more, still more preferably 0.50 or more, and is preferably 50 or less, more preferably 35 or less, even more preferably 20 or less, still more preferably 10 or less, still more preferably 5.0 or less, still more preferably 3.5 or less. <1> ~ <3> , <5> ~ <32> The topical composition according to any one of the above. <34> The mass ratio of component (E) to component (D) in the topical preparation composition [(E) / (D)] is preferably 0.005 or more, more preferably 0.05 or more, even more preferably 0.10 or more, still more preferably 0.16 or more, still more preferably 0.20 or more, and is preferably 3.0 or less, more preferably 2.0 or less, even more preferably 1.0 or less, still more preferably 0.80 or less, still more preferably 0.40 or less. <1> ~ <33> The topical composition according to any one of the above. <35> the mass ratio of component (B) to the total content of component (D) and component (E) in the topical preparation composition [(B) / {(D)+(E)}] is preferably 0.001 or more, more preferably 0.01 or more, even more preferably 0.02 or more, and is preferably 1.0 or less, more preferably 0.50 or less, even more preferably 0.20 or less, still more preferably 0.12 or less, and even more preferably 0.10 or less; <1> ~ <34> The topical composition according to any one of the above. <36> The mass ratio of component (A) to the total amount of component (B) and component (C) in the topical preparation composition [(A) / {(B)+(C)}] is preferably 0.001 or more, more preferably 0.005 or more, even more preferably 0.01 or more, still more preferably 0.05 or more, still more preferably 0.10 or more, and is preferably 5.00 or less, more preferably 3.00 or less, even more preferably 2.50 or less, still more preferably 2.40 or less, still more preferably 2.00 or less, still more preferably 1.60 or less, still more preferably 1.00 or less, still more preferably 0.60 or less. <1> , <4> ~ <35> The topical composition according to any one of the above. <37> <1> ~ <36> A lotion, gel, ointment, cream, or foam formulation comprising the topical composition according to any one of the above. <38> <1> ~ <36> An aerosol formulation or pump spray formulation using the topical composition according to any one of the above. <39> The topical preparation composition and a propellant are contained, and the mass ratio of the topical preparation composition to the propellant is preferably in the range of 1:0.01 to 1:10, more preferably 1:0.05 to 1:7.5. <38> Aerosol formulation of.

[0091] <40> A method for using an external preparation composition, comprising the steps of applying to the skin and then drying an external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity at 25°C of 1.0 mPa·s or more, preferably 3.0 mPa·s or more, more preferably 5.0 mPa·s or more, even more preferably 10.0 mPa·s or more, and 10,000 mPa·s or less, preferably 7,500 mPa·s or less, more preferably 5,000 mPa·s or less, even more preferably 3,000 mPa·s or less, still more preferably 2,000 mPa·s or less, still more preferably 1,000 mPa·s or less, and still more preferably 700 mPa·s or less. <41> A method for using an external preparation composition comprising: applying to the skin and then drying the composition, the external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (E) in the external preparation composition is 0.1% by mass or more and 30% by mass or less, the mass ratio of component (A) to the total amount of components (B) and (C) [(A) / {(B)+(C)}] is 0.001 or more and 2.40 or less, and the viscosity at 25°C is 1.0 mPa s or more and 10,000 mPa s or less. <42> A method for using an external preparation composition comprising: applying to the skin and then drying the composition, the external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (E) in the external preparation composition is more than 30% by mass and not more than 70% by mass, the mass ratio of component (A) to the total amount of components (B) and (C) [(A) / {(B)+(C)}] is 0.001 or more and 2.40 or less, and the viscosity at 25°C is 1.0 mPa s or more and 10,000 mPa s or less. <43> A method for using an external preparation composition comprising: applying to the skin and then drying the composition, the external preparation composition comprising (A) an anti-inflammatory and analgesic ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, wherein the content of component (B) in the external preparation composition is from 0.1% to 15% by mass, the mass ratio of component (C) to component (B) in the external preparation composition [(C) / (B)] is from 0.05 to 3.5, and the viscosity at 25°C is from 1.0 mPa s to 10,000 mPa s. <44> A method for using an external preparation composition comprising: (A) one or more medicinal ingredients selected from the group consisting of glycol salicylate, diclofenac sodium, loxoprofen sodium, felbinac, indomethacin, piroxicam, flurbiprofen, methyl salicylate, ketoprofen, and vanillyl nonylate amide; (B) a water-insoluble polymer; (C) a non-volatile base; (D) a volatile solvent; and (E) water, wherein the content of component (C) in the external preparation composition is 5.0% by mass or less and the viscosity at 25°C is 1.0 mPa·s or more and 10,000 mPa·s or less, and the external preparation composition comprises the steps of applying the composition to the skin and then drying. <45> The topical composition is applied to the skin by spraying. <40> ~ <44> A method for using the topical composition described in any one of the above. <46> The method for spraying the topical composition is a method using an aerosol, a pump spray, or an electrostatic spray device. <45> A method for using the topical composition described in 1. <47> The topical composition is applied to the skin by spraying it using an electrostatic spray device. <45> or <46> A method for using the topical composition described in 1. <48> <1> ~ <36> 1. A method for producing a coating, comprising a step of applying the topical preparation composition according to any one of the above items 1 to the skin by directly applying or spraying it onto the skin. <49> The method for spraying the topical composition is a method using an aerosol, a pump spray, or an electrostatic spray device. <48> A method for producing the coating according to claim 1. <50> The topical composition is applied to the skin by spraying it on the skin using an electrostatic spray device. <48> or <49> A method for producing the coating according to claim 1. [Example]

[0092] The present invention will be described below with reference to examples, but the present invention is not limited to the scope of the examples. In the examples, various measurements and evaluations were carried out by the following methods.

[0093] (SP value) The SP values ​​of the components used in each topical composition were calculated based on Hansen's solubility parameters using solubility parameter calculation software (Hansen Solubility Parameters in Practice 4th Edition 4.1.03). In calculating the SP values, the specific gravities of the polymer components (B) and (B') were set at 1.0.

[0094] (viscosity) The viscosity of each topical composition at 25°C was measured using a vibration viscometer (VM-10AL, manufactured by Sekonic Corporation). For compositions with a viscosity exceeding 1000 mPa·s, the viscosity was measured using a B-type rotational viscometer (TV-10M, manufactured by Toki Sangyo Co., Ltd., rotor: TM3, rotation speed: 6 rpm).

[0095] (pH) The pH of each topical composition at 25°C was measured without dilution using a pH meter ("F-51" manufactured by Horiba, Ltd.).

[0096] (Feeling of use) The topical composition of each example was applied to the inside of the forearm using the tip of a pipette at 6 μL / cm 2 Ten expert panelists evaluated the feel of the product when applied on a 5-point scale for each of the following six items. The average scores of the 10 panelists (rounded to the nearest tenth) are shown in the table. The higher the score, the better the evaluation result. (1) Ease of application to the skin 5: Extremely easy to spread, 4: Easy to spread, 3: Normal, 2: Somewhat difficult to spread, 1: Very difficult to spread (2) Quick drying when applied to the skin 5: Dries within 30 seconds, 4: Dries within 1 minute, 3: Dries within 2 minutes, 2: Dries within 10 minutes, 1: Does not dry in more than 10 minutes (3) Appearance of the coating 5: transparent, 4: slightly whitened but nearly transparent, 3: slightly whitened but transparent, 2: semi-transparent, 1: completely whitened (4) Sticky feeling of the coating 5: Not sticky at all, 4: Slightly sticky, 3: Slightly sticky, 2: Very sticky, 1: Very sticky (5) Tightness 5: No tightness at all, 4: Slight tightness, 3: Slight tightness, 2: Significant tightness, 1: Very tightness (6) Durability of the coating After applying the topical composition to the inside of the forearm, expert panelists performed their daily activities and visually observed the formed film after a certain period of time to check whether the film remained. The longest time during which the film remained was scored according to the following criteria. 5: 8 hours later, 4: 4 hours later, 3: 1 hour later, 2: 30 minutes later, 1: 10 minutes later

[0097] (Storage stability) 10 g of each topical composition was placed in a screw tube No. 4 (manufactured by Maruemu Co., Ltd.), the tube was capped, and the appearance, odor, viscosity, and pH were checked for changes over time after storage in a thermostatic chamber at 0°C and 40°C for one week, and the results were evaluated according to the following criteria. A: No change in appearance, smell, viscosity, or pH B: There is a slight change in one or more of the following: appearance, smell, viscosity, or pH C: There is a change in any one of appearance, smell, viscosity, or pH. D: Changes in two or more of appearance, odor, viscosity, and pH

[0098] (Film forming property) The topical composition of each example was applied to the surface of artificial leather ("Suprare" manufactured by Ideatex Japan Co., Ltd.) at a dose of 6 μL / cm 2 The topical composition was applied to the skin and then dried for 1 hour on a hot plate ("Ceramic Hot Plate" manufactured by AS ONE Corporation) set to 32°C. The applied area of ​​the topical composition was visually observed, and the film-forming ability was judged according to the following criteria. A score of 3 or higher was considered to be acceptable. 5: A uniform and sufficiently thick coating is formed; 4: A uniform and thick coating is formed; 3: A thin but uniform coating is formed; 2: A coating is present but is uneven; 1: The presence of a coating cannot be confirmed.

[0099] (Amount of medicinal ingredients permeated through the skin) The external preparation composition of each example was applied to the surface (one side) of the stratum corneum of a pig's ear placed in a Franz diffusion cell (manufactured by PermeGear) at 6 μL / cm 2 Cumulative skin permeation of active ingredients after 8 hours (μg / cm 2 ) was measured. The higher the value, the higher the permeability of the active ingredient into the skin.

[0100] (Crystallization of medicinal ingredients) On a glass slide, 5 μL / cm of each topical composition was applied. 2 The coating was applied and dried for 1 hour on a hot plate ("Ceramic Hot Plate" manufactured by AS ONE Corporation) set to 32°C. The presence or absence of crystals in the formed coating was evaluated using a polarizing microscope and judged according to the following criteria. The higher the score, the less likely precipitation of the crystalline medicinal ingredient occurred and the better the release of the medicinal ingredient into the skin. 5: No crystals observed, 4: Crystals less than about 10 μm observed, 3: Crystals greater than about 10 μm and less than 50 μm observed, 2: Crystals greater than about 50 μm and less than 100 μm observed, 1: Crystals greater than about 100 μm observed

[0101] (Coating spinnability) On a glass slide, 5 μL / cm of each topical composition was applied. 2 The coating was applied and dried for 1 hour on a hot plate ("Ceramic Hot Plate" manufactured by AS ONE Corporation) set to 32°C. Spinnability was evaluated by touching the surface of the formed coating with a finger and judged according to the following criteria. A higher score indicates that the affinity of the medicinal ingredient with the coating is not excessively high, resulting in lower spinnability and better release of the medicinal ingredient into the skin. 5: no spinnability at all, 4: almost no spinnability, 3: slight spinnability, 2: significant spinnability, 1: very high spinnability

[0102] (Appearance change when stored at -5℃) 10 g of each composition shown in Table 7 was weighed into a transparent vial and stored at -5°C for 6 hours. After storage, the composition was allowed to stand at 20°C for 20 minutes, and the appearance of the composition in the vial was then observed according to the following criteria. Note that the background color of the vial during observation was black. Clear: The composition is transparent and the black background color can be seen without any cloudiness. Slightly cloudy: The composition becomes slightly hazy and the black background appears slightly blurred. Cloudiness: The composition becomes hazy and the black background appears blurred.

[0103] Examples 1 to 42 and Comparative Examples 1 to 10 (Preparation and Evaluation of Topical Compositions) Component (B) or component (B') and other components listed in the table were mixed with component (C), component (D), and component (E) and dissolved uniformly at 30°C. Component (A) was then added and dissolved to prepare an external preparation composition. The obtained topical composition was evaluated by the above-mentioned method, and the results are shown in Tables 1 to 7. The blending amounts listed in each table are the amount of active ingredient (parts by mass) of each component unless stated as "% by mass," and are the amount of active ingredient (% by mass) of each component unless stated as "% by mass." In addition, in the tables, water-soluble polymers that do not fall under component (B) are referred to as "component (B')."

[0104] [Table 1]

[0105] [Table 2]

[0106] [Table 3]

[0107] [Table 4]

[0108] [Table 5]

[0109] [Table 6]

[0110] [Table 7]

[0111] The ingredients and notes in the table are as follows: *1 Felbinac: Manufactured by Fujifilm Wako Pure Chemical Industries, Ltd. *2 Glycol salicylate: manufactured by Tokyo Chemical Industry Co., Ltd. *3 Loxoprofen sodium: Manufactured by Fujifilm Wako Pure Chemical Industries, Ltd. *4 l-Menthol: Takasago International Corporation *5 Vanillyl nonyl amide: manufactured by Tokyo Chemical Industry Co., Ltd. *6 (Acrylates / diacetone acrylamide) copolymer: "Plus Size L-53" manufactured by Goo Chemical Industry Co., Ltd. *7 Hypromellose phthalate: Shin-Etsu Chemical Co., Ltd. "HPMCP HP-55" *8 Acrylamide-methacrylate methoxypolyethylene glycol copolymer: Kao Corporation "RP-77T" *9 Ethyl cellulose: "Ethocel 100P" manufactured by Nisshin Chemical Co., Ltd. *10 Polyvinyl butyral: S-LEC BM-1 manufactured by Sekisui Chemical Co., Ltd. *11 Methyl vinyl ether / maleic anhydride: "Gantrez AN" manufactured by ISP Japan Co., Ltd. *12 Isopropyl myristate: Kao Corporation's "Exepar IPM", specific gravity 0.80 *13 Diethyl sebacate: NOF Corporation "Diethyl Sebacate SP-1", specific gravity 0.94 *14 Oleyl alcohol: Tokyo Chemical Industry Co., Ltd., specific gravity 0.85 *15 Squalane: Fujifilm Wako Pure Chemical Industries, Ltd., specific gravity 0.81 *16 Diisopropanolamine: specific gravity 0.99 *17 Triethanolamine: specific gravity 1.13 *18 2-amino-2-methylpropanol: specific gravity 0.93 *19 Xylitol: Fujifilm Wako Pure Chemical Industries, Ltd., specific gravity 1.52 *20 Example 39 [Δ(SP A -SP B+C )] was calculated for each type of component (A). A -SP B+C ) are, from the top to the bottom, the Δ(SP A -SP B+C )

[0112] From Tables 1 to 6, it can be seen that the topical composition of this example provides good results in terms of sustained release of the medicinal ingredient, film-forming properties, ease of application to the skin, quick drying, the effect of suppressing stickiness and tightness of the formed film, and the appearance and durability of the film. The composition also has good storage stability. Furthermore, Table 7 shows that in the topical composition of this example, when the content of component (E) is more preferably 50% by mass or less, even more preferably 30% by mass or less, even more preferably 25% by mass or less, even more preferably 22% by mass or less, even more preferably 21% by mass or less, and even more preferably 20% by mass or less, cloudiness is less likely to occur even when stored at a low temperature of -5°C, and a good appearance can be maintained. In contrast, Comparative Examples 1, 6, and 7, which did not contain component (B), Comparative Examples 2 and 8, which did not contain component (C), Comparative Example 3, which did not contain component (D), Comparative Example 4, which did not contain component (E), Comparative Example 5, which did not contain components (D) and (E), and Comparative Examples 9 and 10, which had viscosities outside the range specified by the present invention, were inferior to the effects of the present invention in any of the items.

[0113] Formulation Example 1 (Preparation of aerosol formulation) According to the following formulation, component (B) was mixed with components (C), (D), and (E) and dissolved uniformly at 30°C, and then component (A) was added and dissolved to prepare an external preparation composition serving as an aerosol concentrate. This was filled into an aerosol container (manufactured by Toyo Seikan Co., Ltd.), and nitrogen was enclosed so that the aerosol concentrate:nitrogen mass ratio was 1:0.1, thereby preparing an aerosol formulation. (component) (mass%) (A) Peppermint oil 3.0 (B) Polyvinyl alcohol 3.0 (C) Diglycerin 3.4 (D) Ethanol 65.0 (E) Purified water balance Total 100.0 [Industrial Applicability]

[0114] According to the present invention, it is possible to provide an external preparation composition that can sustainably release a medicinal ingredient onto the skin, has good film-forming properties, is easily applied to the skin, dries quickly, and has the effect of suppressing stickiness and a feeling of tightness in the formed film, and is excellent in appearance and durability of the film; a preparation using the same; a method for using the external preparation composition; and a method for producing the film.

Claims

1. A film-forming external preparation composition comprising (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water, and having a viscosity at 25°C of 1.0 mPa·s or more and 10,000 mPa·s or less, Component (A) comprises one or more members selected from the group consisting of glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium, ketoprofen, felbinac, indomethacin, piroxicam, flurbiprofen, glycyrrhizic acid, glycyrrhetinic acid, l-menthol, dl-camphor, nonylic acid vanillylamide, peppermint oil, benzyl nicotinate, sodium polyethylene sulfonate, tocopherol acetate, diphenhydramine, chlorpheniramine maleate, capsicum, eucalyptus oil, and Phellodendron Bark; Component (B) is a polymer having the property that, when 1 g of the polymer is immersed in 10 g of ion-exchanged water under an environment of 23°C and 1 atmosphere, more than 0.5 g of the immersed polymer does not dissolve after 24 hours, and the polymer is selected from the group consisting of (acrylates / diacetoneacrylamide) copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, acrylic acid-octyl acrylate copolymer, acrylic acid ester-vinyl acetate copolymer, 2-ethylhexyl acrylate-methyl acrylate-acrylic acid-glycidyl methacrylate copolymer, 2-ethylhexyl acrylate-vinyl acetate-hydroxyethyl acrylate-glycidyl methacrylate copolymer, acrylic acid ester-vinyl acetate ... the polymer is at least one polymer selected from the group consisting of a 2-ethylhexyl acrylate-diacetoneacrylamide-acetoacetoxyethyl methacrylate-methyl methacrylate copolymer, a 2-ethylhexyl acrylate-vinylpyrrolidone copolymer, a 2-ethylhexyl acrylate-2-ethylhexyl methacrylate-dodecyl methacrylate copolymer, an ethyl acrylate-methyl methacrylate copolymer, an ethyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate chloride copolymer, a methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, polyvinyl alcohol, and polyvinyl butyral; Component (C) is one or more non-volatile bases selected from the group consisting of ester oils, non-polar oils, and alkanolamines, and contains at least one or more non-volatile bases selected from the group consisting of ester oils and non-polar oils, the mass ratio of component (C) to component (B) [(C) / (B)] is 0.2 or more; the mass ratio of the component (E) to the component (D) [(E) / (D)] is 0.005 or more and 2.0 or less; Film-forming topical composition.

2. 2. The film-forming topical composition according to claim 1, wherein component (B) is a polymer that, when 1 g of the polymer is immersed in 10 g of ion-exchanged water under an environment of 23°C and 1 atmosphere, does not dissolve more than 0.5 g of the immersed polymer after 24 hours, and is one or more polymers selected from the group consisting of acrylates / diacetoneacrylamide copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, ethyl acrylate-methyl methacrylate copolymer, ethyl acrylate-methyl methacrylate-trimethylammonium ethyl methacrylate chloride copolymer, methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer, polyvinyl alcohol, and polyvinyl butyral.

3. The film-forming topical composition according to claim 1 or 2, wherein component (B) is a polymer having the property that, when 1 g of the polymer is immersed in 10 g of ion-exchanged water under an environment of 23°C and 1 atmosphere, more than 0.5 g of the immersed polymer does not dissolve after 24 hours, and the polymer is one or more polymers selected from the group consisting of acrylates / diacetoneacrylamide copolymer, acrylamide-methoxypolyethylene glycol methacrylate copolymer, and polyvinyl butyral.

4. 4. The film-forming topical composition according to claim 1, wherein component (C) is at least one selected from the group consisting of isopropyl myristate, dibutyl adipate, diethyl sebacate, diisopropyl sebacate, triethanolamine, monoethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol.

5. A film-forming topical composition according to any one of claims 1 to 4, wherein component (C) is one or more selected from the group consisting of isopropyl myristate, diethyl sebacate, triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol.

6. A film-forming topical composition according to any one of claims 1 to 5, wherein component (A) comprises one or more selected from the group consisting of glycol salicylate, loxoprofen sodium, felbinac, l-menthol, and vanillyl nonylate amide.

7. The film-forming topical composition according to any one of claims 1 to 6, wherein component (D) is a lower alcohol.

8. The film-forming topical composition according to any one of claims 1 to 7, wherein the content of component (A) in the film-forming topical composition is 0.001% by mass or more and 30% by mass or less.

9. 9. The film-forming topical composition according to claim 1, wherein the content of component (B) in the film-forming topical composition is 0.01% by mass or more and 30% by mass or less.

10. The film-forming topical composition according to any one of claims 1 to 9, wherein the content of component (C) in the film-forming topical composition is 0.001% by mass or more and 30% by mass or less.

11. The film-forming topical composition according to any one of claims 1 to 10, wherein the content of component (D) in the film-forming topical composition is 10% by mass or more and 95% by mass or less.

12. The film-forming topical composition according to any one of claims 1 to 11, wherein the content of component (E) in the film-forming topical composition is 0.1% by mass or more and 70% by mass or less.

13. The film-forming topical composition according to any one of claims 1 to 12, wherein the mass ratio of component (C) to component (B) in the film-forming topical composition [(C) / (B)] is 0.2 or more and 50 or less.

14. A lotion preparation, gel preparation, ointment preparation, cream preparation, or foam preparation comprising the film-forming topical preparation composition according to any one of claims 1 to 13.

15. An aerosol formulation or pump spray formulation using the film-forming topical composition according to any one of claims 1 to 13.

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